U.S. patent application number 12/792072 was filed with the patent office on 2010-12-02 for bone screw assembly for limited angulation.
This patent application is currently assigned to ALPHATEC SPINE, INC.. Invention is credited to Srilakshmi VISHNUBHOTLA, Benjamin WANG.
Application Number | 20100305621 12/792072 |
Document ID | / |
Family ID | 43221082 |
Filed Date | 2010-12-02 |
United States Patent
Application |
20100305621 |
Kind Code |
A1 |
WANG; Benjamin ; et
al. |
December 2, 2010 |
BONE SCREW ASSEMBLY FOR LIMITED ANGULATION
Abstract
A limited angulation bone screw assembly adapted to couple a
spinal rod with a vertebra including a bone screw, a bushing and a
housing. The pedicle screw having a shaft and an upper head
portion, the upper head portion comprising a spherical surface with
flats disposed on opposite sides of the upper head portion. The
bushing comprising a lower rounded surface for mating with the
spherical surface and flats of the upper head portion to restrict
the angular movement of the bone screw. The coupled bone screw and
bushing are inserted into the housing in a first orientation and
then rotated to a second orientation to secure the coupled bone
screw and bushing to complete the housing.
Inventors: |
WANG; Benjamin; (Carlsbad,
CA) ; VISHNUBHOTLA; Srilakshmi; (San Diego,
CA) |
Correspondence
Address: |
ALPHATEC SPINE, INC.
5818 EL CAMINO REAL
CARLSBAD
CA
92008
US
|
Assignee: |
ALPHATEC SPINE, INC.
Carlsbad
CA
|
Family ID: |
43221082 |
Appl. No.: |
12/792072 |
Filed: |
June 2, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61183270 |
Jun 2, 2009 |
|
|
|
Current U.S.
Class: |
606/305 ;
29/428 |
Current CPC
Class: |
A61B 17/8605 20130101;
A61B 17/7037 20130101; Y10T 29/49826 20150115; A61B 17/7038
20130101 |
Class at
Publication: |
606/305 ;
29/428 |
International
Class: |
A61B 17/86 20060101
A61B017/86; B23P 11/00 20060101 B23P011/00 |
Claims
1. A limited angulation bone screw assembly adapted to couple a
spinal rod with a vertebra, comprising: a bone screw (10)
comprising a threaded shaft (13) and an upper head portion (20),
the upper head portion (20) being a substantially spherical surface
(23) having flat surfaces (18) disposed on opposite sides of the
upper head portion (20); a bushing (30) comprising an upper portion
(31) having a seat (33) shaped to receive the spinal rod and
shoulders (38) on both sides of the seat, and a lower portion (32)
having a rounded surface (35) and a pair of opposing flanges (43)
having inner planar surfaces (46) shaped to slidably couple with
the spherical surface (23) and flats (18) of the bone screw (10) to
restrict motion of the bone screw to a single plane; and a housing
(50) having an upper portion (53) with a first opening (67), a
lower portion (56) with a second opening (69), and a first axis
(63) extending between the upper and lower portions, the upper
portion (53) comprising two spaced apart arms (55), each arm
comprising internal threads (61) and an internal groove (87)
configured to receive the shoulder (38) of the bushing (30), and a
U-shaped channel (74) extending along a second axis transverse to
the first axis (63) adapted to receive the rod member, and the
second opening (69) being sized to engage the upper head portion
(20) of the bone screw (10); wherein the screw is insertable
through the first opening (67) until the threaded shaft (13)
extends through the second opening (69) and the upper head portion
(20) engages the second opening (69); wherein the bushing (30) is
insertable through the first opening (67) in a first orientation
with the shoulders (38) being positioned between the spaced apart
arms (55) until the shoulders (38) are proximate to the internal
grooves (87), the bushing (30) then being rotateable to a second
orientation with the shoulders (38) being inserted into the
internal grooves (87) and the bushing seat (33) aligning with the
U-shaped channel (74); and wherein the upper head portion (20) of
the screw couples with the lower portion (32) of the bushing (30)
and permits angulation of the housing (50) relative to the bone
screw (10) in a plane including the first and second axis.
2. The bone screw assembly of claim 1, wherein the bushing (30)
further comprises a groove (39) adjacent the shoulder (38).
3. The bone screw assembly of claim 2, wherein the housing further
includes one or more protruding members configured to mate with the
groove (39).
4. The bone screw assembly of claim 2, wherein the groove (39) is
configured for frictional engagement with the housing.
5. The bone screw assembly of claim 1, wherein prior to insertion
through the first opening (67), the upper head portion (20) of the
screw (10) is engaged with the lower portion (32) of the bushing
(30) in the first orientation, and after insertion of both the
bushing (30) and screw (10) when the shoulders (38) are proximate
the internal grooves (87), both the bushing (30) and screw (10) are
rotated to the second orientation.
6. The bone screw assembly of claim 1, wherein the lower portion
(32) of the bushing (30) further includes cut-away portions (41)
formed along a bottom circumferential surface (42).
7. The bone screw assembly of claim 6, wherein the cut-away
portions (41) are configured to splay over the upper head portion
(20) of the screw (10) when the bushing (30) is in a crush locked
position.
8. The bone screw assembly of claim 1, wherein the flat surfaces
(18) includes protrusions (23a').
9. The bone screw assembly of claim 1, further comprising a set
screw having external threads configured to engage the internal
threads (61) of the housing (50).
10. The bone screw assembly of claim 1, wherein the upper portion
(53) further comprising a recess (72) configured to interface with
an instrument interface.
11. A limited angulation bone screw assembly, comprising: a bone
screw comprising a shaft and a substantially spherical upper head
portion having flat surfaces disposed on opposite sides of the
upper head portion; a bushing having an upper portion and a lower
portion, the lower portion configured to mate with the upper head
portion and the flat surfaces of the bone screw to restrict motion
of the bone screw to a single plane and the upper portion having a
seat shaped to receive the spinal rod and shoulders on both sides
of the seat; and a housing having an upper portion, a lower portion
and a first axis extending between the upper and lower portions,
the housing having a first opening at the upper portion, a second
opening at the lower portion and internal grooves configured to
receive the shoulders of the bushing; wherein the mated bushing and
screw are insertable through the first opening in a first
orientation until the shaft extends through the second opening and
the shoulders are proximate the internal grooves, the bushing and
screw then being rotateable to a second orientation with the
shoulders being inserted into the internal grooves, and wherein the
seat aligns with the upper portion of the housing to receive a
spinal rod therein along a second axis transverse to the first
axis.
12. The bone screw assembly of claim 11, wherein the bushing
further comprises a groove adjacent the shoulder and the housing
further includes one or more protruding members configured to mate
with the groove.
13. The bone screw assembly of claim 11, wherein the bushing
further comprises a groove adjacent the shoulder configured for
frictional engagement with the housing.
14. The bone screw assembly of claim 11, wherein the lower portion
of the bushing further includes cut-away portions formed along a
bottom circumferential surface, the cut-away portions being
configured to splay over the upper head portion of the screw when
the bushing is in a crush locked position.
15. The bone screw assembly of claim 11, wherein the flat surfaces
includes protrusions.
16. The bone screw assembly of claim 11, further comprising a set
screw having external threads configured to engage internal threads
within the housing.
17. The bone screw assembly of claim 11, wherein the upper portion
further comprising a recess configured to interface with an
instrument interface.
18. A method of assembling a bone screw assembly capable of
uniplanar movement, comprising: providing a bone screw comprising a
shaft and an upper head portion, the upper head portion comprising
a spherical surface adjacent first planar surfaces; providing a
bushing, the bushing comprising an upper portion and a lower
portion, the upper portion comprising a groove, the lower portion
defining a lower rounded surface, the lower portion further
comprising flanges having second planar surfaces; coupling first
planar surfaces of the bone screw with second planar surfaces of
the bushing to thereby restrict movement of the bone screw to a
single plane; providing a housing having an upper portion, a lower
portion and a first axis extending between the upper and lower
portions, the housing having a first opening at the upper portion
and a second opening at the lower portion, the housing further
comprising an inner groove for receiving the shoulder of the
bushing; delivering the bone screw and bushing into the housing;
and rotating the bushing until the shoulder of the bushing is
received in a groove of the housing.
19. The method of claim 18, wherein delivering comprises
drop-loading the bone screw downwardly into the housing, followed
by drop-loading the bushing into the housing on top of the bone
screw.
20. The method of claim 18, wherein delivering comprises
drop-loading the bone screw and bushing downwardly together into
the housing.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/183,270 filed Jun. 2, 2009, entitled "Bone Screw
Assembly For Limited Angulation", the contents of which is
incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] Embodiments of the present application are directed to a
bone screw assembly for use in spinal surgery and in particular, to
a bone screw assembly having restricted angular movement to a
single plane.
[0003] Surgical intervention is often required to treat injuries
and deformities of the spine. Scoliosis is one type of deformity of
the spinal column having three components: coronal plane deformity,
which is a side bending of the spine when viewed from the front or
back; sagittal plane deformity, which is a loss of normal kyphotic
curvature in the thoracic or chest area when viewed from the side;
and axial plane deformity, which is a rotation of the spine around
its own axis.
[0004] For rotational deformities of the spine, de-rotation
maneuvers may need to be performed in-situ. Such de-rotation
maneuvers place mechanical loads on the screw body in the sagittal
plane, where resistance to lateral de-rotation forces is required
to adequately correct the anatomy and restore alignment. It is
therefore desirable to have bone screw assemblies suitable for
de-rotation maneuvers, and preferably, for bone screw assemblies
that allow for greater acceptance of rod deformities during
construct.
SUMMARY
[0005] The bone screw assembly and methods described herein include
a bone screw, a bushing and a housing. The pedicle screw having a
shaft and an upper head portion, the upper head portion comprising
a spherical surface with flats disposed on opposite sides of the
upper head portion. The bushing comprising a lower rounded surface
for mating with the spherical surface of the upper head portion and
flanges coupled to the flats of the upper head portion to restrict
the angular movement of the bone screw, preferably to a single
plane. The coupled bone screw and bushing are inserted into the
housing in a first orientation and then rotated to a second
orientation to secure the coupled bone screw and bushing to
complete the assembly.
[0006] In a first aspect, embodiments of the present invention
provide a limited angulation bone screw assembly adapted to couple
a spinal rod with a vertebra, the assembly including a bone screw
comprising a threaded shaft and an upper head portion, the upper
head portion being a substantially spherical surface having flat
surfaces disposed on opposite sides of the upper head portion. A
bushing comprising an upper portion having a seat shaped to receive
the spinal rod and shoulders on both sides of the seat, and a lower
portion having a rounded surface and a pair of opposing flanges
having inner planar surfaces shaped to slidably couple with the
spherical surface and flats of the bone screw to restrict motion of
the bone screw to a single plane. A housing having an upper portion
with a first opening, a lower portion with a second opening, and a
first axis extending between the upper and lower portions, the
upper portion comprising two spaced apart arms, each arm comprising
internal threads and an internal groove configured to receive the
shoulder of the bushing, and a U-shaped channel extending along a
second axis transverse to the first axis adapted to receive the rod
member, and the second opening being sized to engage the upper head
portion of the bone screw. Wherein the screw is insertable through
the first opening until the threaded shaft extends through the
second opening and the upper head portion engages the second
opening and the bushing is insertable through the first opening in
a first orientation with the shoulders being positioned between the
spaced apart arms until the shoulders are proximate the internal
grooves, the bushing then being rotateable to a second orientation
with the shoulders being inserted into the internal grooves and the
bushing seat aligning with the U-shaped channel and the upper head
portion of the screw couples with the lower portion of the bushing
and permits angulation of the housing relative to the bone screw in
a plane including the first and second axis.
[0007] In another aspect, embodiments of the present invention
provide a limited angulation bone screw assembly having a bone
screw comprising a shaft and a substantially spherical upper head
portion having flat surfaces disposed on opposite sides of the
upper head portion, a bushing having an upper portion and a lower
portion, the lower portion configured to mate with the upper head
portion and the flat surfaces of the bone screw to restrict motion
of the bone screw to a single plane and the upper portion having a
seat shaped to receive the spinal rod and shoulders on both sides
of the seat, and a housing having an upper portion, a lower portion
and a first axis extending between the upper and lower portions,
the housing having a first opening at the upper portion, a second
opening at the lower portion and internal grooves configured to
receive the shoulders of the bushing. Wherein the mated bushing and
screw are insertable through the first opening in a first
orientation until the shaft extends through the second opening and
the shoulders are proximate the internal grooves, the bushing and
screw then being rotateable to a second orientation with the
shoulders being inserted into the internal grooves, and the seat
aligns with the upper portion of the housing to receive a spinal
rod therein along a second axis transverse to the first axis.
[0008] In many embodiments, the bushing may have a groove adjacent
the shoulder. In some embodiments the housing may include one or
more protruding members configured to mate with the groove. In
other embodiments, the groove may provide frictional engagement
with the housing.
[0009] In many embodiments, the lower portion of the bushing
further includes cut-away portions formed along a bottom
circumferential surface. In some embodiments the cut-away portions
are configured to splay over the upper head portion of the screw
when the bushing is in a crush locked position.
[0010] In many embodiments, the bone screw assembly further
includes a set screw having external threads configured to engage
the internal threads of the housing.
[0011] In many embodiments, the upper portion further comprising a
recess configured to interface with an instrument interface.
[0012] In another aspect, embodiments of the present invention
provide a method of assembling a bone screw assembly capable of
uniplanar movement is provided, the method including a bone screw,
the bone screw having a spherical surface adjacent first planar
surfaces; providing a bushing, the bushing comprising flanges
having second planar surfaces; coupling the first planar surfaces
of the bone screw with the second planar surfaces of the bushing to
restrict movement of the bone screw to a single plane; providing a
housing and delivering the coupled bone screw and bushing into the
housing; and rotating the coupled bone screw and bushing to secure
the coupled bone screw and bushing to the housing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of a bone screw according to
some embodiments of the present application.
[0014] FIG. 2 is a perspective view of a bushing according to some
embodiments of the present application.
[0015] FIG. 3 is a perspective view of a bone screw coupled with a
bushing according to some embodiments of the present
application.
[0016] FIG. 4A is a perspective view of a housing according to some
embodiments of the present application.
[0017] FIG. 4B is a perspective view of a housing with a bone screw
inserted therein according to some embodiments of the present
application.
[0018] FIGS. 5A-5C are side perspective views of a bone screw
assembly in various stages of assembly according to some
embodiments.
[0019] FIGS. 6A-6B are cross-sectional views of a bone screw
assembly according to some embodiments of the present
application.
[0020] FIGS. 7A-7D are perspective views of another embodiment of a
bone screw assembly in various stages of assembly.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0021] Embodiments of the present application are directed to a
bone screw assembly and in particular, to a bone screw assembly
capable of having restricted angular movement, such as movement
that is restricted to a single plane. In some embodiments, the bone
screw assembly can be used in spinal surgery, such as in pedicles.
In some embodiments, the bone screw assembly can be inserted into
the sacrum or the iliac. The bone screw assembly is adapted to
receive a rod or other rigid member and to secure the rod to one or
more vertebra. In some embodiments, the bone screw assembly
includes a bone screw having an angulation relative to a housing
that is restricted in one directions or planes. As used herein
"angulation" describes the ability or lack thereof of the screw
being positionable in a range of positions in which a range of
angles is formed between the screw and the housing. In a preferred
embodiment, the bone screw assembly includes a bone screw having
movement restricted to only in a single plane. Such a screw is
capable of providing angulation only in that plane.
[0022] In some embodiments, the screw assemblies described herein
comprise lightweight, low profile bone screw assembly that are
constructed to allow each component thereof to secure other pieces
within the overall structure to minimize the risk of disassembly
when in use.
[0023] In some embodiments, a bone screw assembly 5 comprises a
bone screw 10, a bushing 30 and a housing 50 (shown in FIGS. 1-4).
According to some embodiments, when all the components are fully
assembled, the bone screw 10 can pivot and achieve various angles
relative to another component of the screw (e.g., the housing as
discussed below) only along a single plane. In a preferred
embodiment, the bone screw 10 is assembled and placed in a patient
such that the bone screw 10 pivots or angulates only along a
cephalad-caudal plane. Preferably, the bone screw assembly allows
the housing 50 to angulate cephalad-caudally to accept a rod, but
resists movement (e.g., is rigid) in the medial-lateral plane to
allow for the transferring of de-rotation forces to vertebral
movement. In contrast, polyaxial screws would respond to such
forces by being deflected. Thus, this application describes bone
screw assemblies that combine the force transferring advantages of
a monoaxial fixed screw head with the variable head positioning of
a polyaxial screw. An additional benefit of having a bone screw 10
that is restricted to angulation only along a cephalad-caudal plane
is that this allows for greater acceptance of deformity rods during
spinal surgeries.
[0024] FIG. 1 illustrates a bone screw 10 according to some
embodiments of the present application. The bone screw 10 comprises
a threaded shaft 13, a neck 16, and an upper head portion 20
attached to the threaded shaft 13 by the neck 16. The shaft 13 is
elongate and has a lower body ending in a tip (shown in FIGS.
5A-5C) that is implantable into a bone. The threaded shaft 13
includes a number of helical threads extending radially outward
from and along at least a portion of the length of the shaft. The
neck 16 comprises a cylindrically shaped portion that is located
between and connects the threaded shaft 13 to the upper head
portion 20.
[0025] The upper head portion 20 comprises a spherical surface 23
adjacent a plurality of flat surfaces or flats 18. In some
embodiments, the flats 18 comprise a circular or an oval region of
the head. In other embodiments, non-flat surfaces capable of
coupling with other surfaces of a screw assembly to limit
angulation are adjacent spherical surface 23. As shown in FIG. 1,
in some embodiments, the upper head portion 20 comprises two flats
18 that are disposed on opposite sides of the spherical surface 23.
The flats 18 can be symmetrical at least in part. In other
embodiments, a single flat or more than two flats (e.g., three or
four), can be provided on the upper head portion 20. As described
in more detail below, the flats 18 cooperate with other surfaces of
a screw assembly to limit angulation, such as by coupling with
corresponding surfaces. In various embodiments described below, the
flats 18 are configured to couple with extended flanges 43 of the
bushing 30.
[0026] FIG. 2 illustrates the bushing 30 according to some
embodiments of the present application. The bushing 30 comprises an
upper portion 31, a lower portion 32, and an axial bore 34 running
therethrough. The upper portion 31 comprises a surface or seat 33
for receiving a rod member. The seat 33 can be shaped to form a
portion of a U-shaped channel, as discussed further below. The
upper portion 31 of the bushing 30 also includes a shoulder 38
adjacent a groove 39. In some embodiments, the shoulder 38 allows
one or more instruments to easily grasp and secure the bushing 30.
In some embodiments, the shoulder 38 serves to prevent disassembly
after the bushing 30 is inserted into a housing member 50 by
sliding or snapping into a corresponding groove inside the housing
member 50 (shown best in FIGS. 6A and 6B) to prevent the bushing 30
from backing out of assembly. The groove 39, adjacent the shoulder
38, forms a track around the top surface of the bushing 30. In some
embodiments, one or more protruding members of the housing can mate
with the bushing 30 by slideably engaging in the groove 39. In some
embodiments, the groove 39 of the bushing 30 helps to prevent
migration of the bushing 30 in the housing 50. In some embodiments,
the groove 39 adds friction between the bushing 30 and the housing
50 to help lock the angulation of the bone screw 10 in place after
the bushing 30 is crush-locked into place with the bone screw 10 by
a set screw as discussed below. While FIG. 2 illustrates the groove
39 extending along the entire top surface of the bushing 30, in
some embodiments, the groove 39 is formed only along a portion of
the top surface of the bushing 30. In some embodiments, the groove
is formed on the top surface of the bushing 30 on both sides of the
U-shaped channel, as shown in FIG. 2.
[0027] The lower portion 32 of the bushing 30 comprises a lower
rounded surface 35 in the interior of the bushing 30 and a
plurality of flanges 43 that extend below the bottom
circumferential surface 42. The lower portion 32 can also include
cut-away portions 41 formed along the bottom circumferential
surface 42 of the bushing in some embodiments.
[0028] The lower portion 32 of the bushing 30 includes lower
rounded surface 35 located in the interior of the bushing 30. The
lower rounded surface 35 surrounds axial bore 34 and is shaped to
mate or couple with the spherical surface 23 of the bone screw 10
when the bushing 30 is brought into contact with the bone screw
10.
[0029] The lower portion 32 of the bushing 30 also includes one or
more flanges 43 that extend below bottom circumferential surface
42. As shown in FIG. 2, in some embodiments, the flanges 43
comprise flat or planar surfaces 46 that face inwardly (toward the
axis 34). The planar surfaces 46 are constructed to mate or couple
with at least a portion of the surfaces of the flats 18 to assist
in coupling the bushing 30 to the bone screw 10. In some
embodiments, when coupled with the flats 18 of the bone screw 10,
the planar surfaces 46 of the flanges 43 restrict the angular
movement of the bone screw 10 relative to the housing 50. In a
preferred embodiment, when coupled with the flats 18 of the bone
screw 10, the planar surfaces 46 of the flanges 43 restrict the
angular movement of the housing to a single plane relative to the
bone screw 10 when the bone screw is in a fixed position (e.g.,
when anchored in a vertebra). For example, a frictional engagement
of the flanges 43 with the flats 18 could enable the housing 50 to
remain in a selected position relative to the screw 10. In other
embodiments, the inner surfaces of the flanges 43 need not be
planar, but can be of any suitable non-planar shape capable of
coupling with the bone screw head 10 to restrict the motion
thereof, e.g., in a uniplanar manner.
[0030] While in some embodiments the flanges 43 are rigid members,
in other embodiments, the flanges 43 are relatively flexible
members that are capable of some degree of splaying when placed in
contact with a portion of the upper head portion 20 of the bone
screw 10. Splaying provides the advantage of allowing the flanges
43 to provide a compressive force on the flats 18 when the bushing
30 is coupled to the bone screw 10, thereby assisting in keeping
the bushing 30 snug with the upper head portion 20 of the bone
screw 10. In some embodiments, the flanges 43 apply a compressive
force against the flats 18 of the bone screw 10 to couple the two
components together after providing and tightening a set screw as
described below.
[0031] In some embodiments, the lower portion 32 of the bushing 30
also includes cut-away portions 41 formed along the bottom
circumferential surface 42 of the bushing 30. The cut-away portions
41 serve as notches that allow for effective crushing of the
bushing 30 over the upper head portion 20 of the bone screw 10 when
a set screw is tightened. In some embodiments, the cut-away
portions 41 allows splaying of the lower portion of the bushing 30
around the upper head portion 20 of the bone screw 10 when the
bushing 30 is crush locked into position with the bone screw 10 by
tightening of a set screw.
[0032] FIG. 3 illustrates a perspective view of a bone screw 10
coupled with a bushing 30 according to embodiments of the present
application. The inner planar surfaces 46 of the bushing 30 extend
downwardly adjacent to, and, in some cases in contact with, the
flats 18 of the bone screw 10. In some cases, the planar surfaces
46 provide a coupling between the bushing 30 and the bone screw 10.
As shown in FIG. 3, in some embodiments, when the bushing 30 is
coupled with the bone screw 10, the planar surfaces 46 of the
flanges 43 contact a portion of the surface area of the flats 18.
While in some embodiments, the planar surfaces 46 of the flanges 43
contact a minimal portion of the surface area of the flats 18
(e.g., less than 50% of the surface area), in other embodiments,
the planar surfaces 46 of the flanges 43 contact a majority of the
surface area of the flats 18, as shown in FIG. 3.
[0033] FIG. 4A illustrates a perspective view of a housing 50
according to some embodiments of the present application, while
FIG. 4B illustrates a perspective view of the housing 50 with a
bone screw 10 received therein. The housing 50 is a cylindrically
shaped member in some embodiments that comprises an upper portion
53, a lower portion 56, and a first axis 63 extending between the
upper and lower portions. In some embodiments, the upper portion 53
comprises two spaced apart upstanding arms 55 defining, at least in
part, a U-shaped channel 74 extending along a second axis
transverse to the first axis 63. Each of the arms 55 contains
internal threads 61. In some embodiments, the internal threads 61
comprise helical structures capable of interlocking with
complementary surfaces as found for example in U.S. Pat. No.
6,726,689 to Jackson, filed Sep. 6, 2009, and herein incorporated
by reference in its entirety and included in an appendix below. The
top of the arms 55 form the first opening 67 at the top of the
housing 50. The arms 55 are disposed on opposite sides of the axis
63 and can be shaped similarly (e.g., minor images of each other),
although in some embodiments, one arm can be sized or shaped
differently from another. The upper portion 53 of the housing also
includes a hole, opening, or recess 72 for receiving a protruding
member of an instrument (e.g. a sleeve or rod reducer).
[0034] The lower portion 56 of the housing 50 comprises a second
opening 69 through which at least a portion of the bone screw 10
extends. For example, as illustrated in FIG. 4B, during assembly,
the bone screw 10 passes through the second opening 69 such that at
least a portion of the upper head portion 20 of the bone screw 10
is retained in the interior of the housing 50, while at least a
portion of the threaded shaft 13 is disposed outside of the housing
50. To retain the coupled bone screw 10 and bushing 30 in the
housing 50, in some embodiments, the housing 50 includes internal
protrusions (not shown) that can slideably engage the grooves 39 of
the bushing 30 upon drop loading, press fitting and rotation of the
bushing 30 in the housing 50. In other embodiments, to retain the
coupled bone screw 10 and bushing 30 in the housing, the housing 50
includes an internal groove 87 that receives the shoulder 38 of the
bushing 30 (as shown in FIGS. 6A and 6B) to secure the
assembly.
[0035] FIGS. 5A-5C illustrate various stages of assembly of the
bone screw assembly 5 according to some embodiments of the present
application. Methods of assembly can comprise providing a bone
screw 10, inserting the bone screw 10 into a housing 50, coupling
the bone screw 10 with a bushing 30, and rotating the bushing 30
within the housing 50.
[0036] As shown in FIG. 5A, a bone screw 10 is provided. In some
embodiments, the bone screw 10 can comprise an upper head portion
20 that is at least partially separate from the threaded shaft 13,
and which may therefore need to be assembled. However, as shown in
FIG. 5A, the bone screw 10 comprises a threaded shaft 13 already
attached to the head portion 20 by a neck 16. In some embodiments,
the threaded shaft 13 and upper head portion 20 are formed from a
monolithic piece. In some embodiments, the bone screw 10 is
drop-loaded downwardly (e.g., top-loaded) into the first opening 67
of the housing 50 before the bushing 30 is coupled with the bone
screw 10. The second opening 69 of the housing 50 is sized smaller
than the diameter of the top portion 20 of the bone screw 10 such
that the bone screw 10 can be drop-loaded into the housing 50 so
that the bone screw 10 rests within the housing 50. As shown in
FIGS. 6A and 6B, a bottom surface of the upper head portion 20 can
abut internal walls 82 of the housing 50.
[0037] After the bone screw 10 is drop-loaded into the housing 50,
the bushing 30 can be drop-loaded downwardly (e.g., top-loaded)
into the housing 50 to couple with the bone screw 10. An
illustration of a coupled bushing 30 and bone screw 10 is shown in
FIG. 5B. In some embodiments, to couple the bushing 30 with the
bone screw 10, the bushing 30 can be press-fitted into contact with
at least the partial spherical surface 23 of the bone screw 10.
Such insertion can cause the lower rounded surface 35 of the
bushing 30 to engage the surface 23. In this position, the flanges
43 can be disposed adjacent to or directly couple with the flats 18
of the bone screw 10.
[0038] To drop-load the bushing 30 into the housing 50, the bushing
30 should be about 90 degrees offset from its final assembly
position to allow the bushing 30 to clear the internal threads 61
of the housing 50 (shown in FIGS. 6A-6B). Once the bushing 30 rests
on the bone screw 10, the bushing can be rotated within the housing
50 to secure the bushing 30 to the housing 50. For example, the
bushing 30 can be rotated within the housing 50 such that the
shoulder 38 of the bushing 30 rests within an internal groove 87 of
the housing 50, thereby securing the components together. In some
embodiments, the coupled bone screw 10 and bushing 30 are rotated
between 1 and 90 degrees, while in other embodiment, these
components are rotated between 30 and 90 degrees, within the
housing 50 to ensure that the internal protrusions within the
housing 50 are slideably engaged in the grooves 39 of the bushing
30.
[0039] When fully assembled, the bone screw 10, bushing 30 and
housing 50 form a bone screw assembly capable of angulation in a
limited number of planes. In some embodiments, even after the
bushing 30 is press-fitted with the bone screw 10 and rotated into
place in the housing 50, the bushing 30 rests loosely inside the
housing 50 and allows for polyaxial freedom of movement. In a
preferred embodiment, the bone screw assembly restricts angulation
of the bone screw to a single plane. Arrow 75 (shown in FIG. 5C)
illustrates the direction of rotation or pivoting of the bone screw
10 relative to the housing 50. As shown, bone screw 10 is capable
of angular movement only along a single plane, e.g., the direction
indicated by the arrow 75. In some embodiments, the bone screw 10
of the bone screw assembly 5 can pivot or angulate between 0 and
nearly 90 degrees in a single plane. For example, the bone screw 10
can pivot or angulate between +/-45 degrees from the axis 63.
[0040] Following assembly of the bone screw 10, bushing 30 and
housing 50, an implant or rod member (not shown) can be delivered
down the housing 50 and past the internal threads 61 and rest on
top of the top portion 20 of the bone screw 10. After delivering
the rod member, a cap or set screw (not shown) can be delivered
downwardly through the housing 50. The set screw comprises external
threads that mate with the internal threads 61 of the housing 50.
The set screw can apply a downward tightening or compression force
on the rod member. The compression force is translated to the
bushing 30, and the bushing 30 is deformed within the housing 50
(sometimes referred to herein as being "crushed" or "crush-locked")
into more complete contact with the bone screw 10, thereby locking
the bone screw 30 at a fixed angle with respect to the housing
50.
[0041] FIGS. 7A-7D illustrate another embodiment of a bone screw
assembly 5'. Methods of assembly can comprise providing a bone
screw 10', inserting the bone screw 10' into a housing 50, coupling
the bone screw 10' with a bushing 30, and rotating the bushing 30
within the housing 50.
[0042] FIG. 7A illustrates a bone screw 10' according to some
embodiments of the present application. The bone screw 10'
comprises a threaded shaft 13, a neck 16, and an upper head portion
20' attached to the threaded shaft 13 by the neck 16. The shaft 13
is elongate and has a lower body ending in a tip that is
implantable into a bone. The threaded shaft 13 includes a number of
helical threads extending radially outward from and along at least
a portion of the length of the shaft. The neck 16 comprises a
cylindrically shaped portion that is located between and connects
the threaded shaft 13 to the upper head portion 20'.
[0043] The upper head portion 20' comprises a spherical surface 23'
adjacent flat surfaces or flats 18' that are disposed on opposite
sides of the spherical surface 23'. Flats 18' are similar to flats
18 described above except flats 18' do not form a circular or an
oval region of the head portion 20'. Instead, a portion of the
spherical surface or protrusion 23a' extends outside of the flats
18' below the bushing engagement area to add lateral support in
medial-lateral bending loading modes (such as derotation) by
leaving material on the spherical tip.
[0044] Similar to the embodiments disclosed above, the flats 18'
cooperate with other surfaces of a screw assembly to limit
angulation, such as by coupling with corresponding surfaces of the
bushing 30 and housing 50. In addition, portions or protrusion 23a'
also interact with the bushing 30 and housing 50 to increase
resistance off-axis angulation of the screw 10'.
[0045] In some embodiments, the bone screw 10' is drop-loaded
downwardly (e.g., top-loaded) into the first opening 67 of the
housing 50 before the bushing 30 is coupled with the bone screw 10.
The second opening 69 of the housing 50 is sized smaller than the
diameter of the top portion 20 of the bone screw 10' such that the
bone screw 10' can be drop-loaded into the housing 50 so that the
bone screw 10' rests within the housing 50.
[0046] After the bone screw 10' is drop-loaded into the housing 50,
the bushing 30 can be drop-loaded downwardly (e.g., top-loaded)
into the housing 50 to couple with the bone screw 10.
[0047] In some embodiments, to couple the bushing 30 with the bone
screw 10', the bushing 30 can be press-fitted into contact with at
least the partial spherical surface 23' of the bone screw 10',
shown in FIG. 7B. Such insertion can cause the lower rounded
surface 35 of the bushing 30 to engage the surface 23'. In this
position, the flanges 43 can be disposed adjacent to or directly
couple with the flats 18' of the bone screw 10'.
[0048] To drop-load the bushing 30 into the housing 50, the bushing
30 should be rotated about 90 degrees offset from its final
assembly position, first orientation, to allow the bushing 30 to
clear the internal threads 61 of the housing 50 (shown in FIG. 7C).
Once the bushing 30 shoulders 38 are proximate the internal grooves
87, the bushing can be rotated within the housing 50 to a second
orientation to secure the bushing 30 to the housing 50. For
example, the bushing 30 can be rotated within the housing 50 such
that the shoulder 38 of the bushing 30 rests within an internal
groove 87 of the housing 50, thereby securing the components
together. In some embodiments, the coupled bone screw 10 and
bushing 30 are rotated between 1 and 90 degrees, while in other
embodiment, these components are rotated between 30 and 90 degrees,
within the housing 50 to ensure that the internal protrusions
within the housing 50 are slideably engaged in the grooves 39 of
the bushing 30.
[0049] When fully assembled, the bone screw 10', bushing 30 and
housing 50 form a bone screw assembly 5' capable of angulation in a
limited number of planes, shown in FIG. 7D. In some embodiments,
even after the bushing 30 is press-fitted with the bone screw 10
and rotated into place in the housing 50, the bushing 30 rests
loosely inside the housing 50 and allows for uniaxial freedom of
movement. In a preferred embodiment, the bone screw assembly
restricts angulation of the bone screw to a single plane. In some
embodiments, the bone screw 10' of the bone screw assembly 5' can
pivot or angulate between 0 and nearly 90 degrees, or between 10
and 80 degrees, in a single plane. For example, the bone screw 10
can pivot or angulate between +/-45 degrees from the axis 63.
[0050] Following assembly of the bone screw 10', bushing 30 and
housing 50, an implant or rod member (not shown) can be delivered
down the housing 50 and past the internal threads 61 and rest on
top of the top portion 20' of the bone screw 10'. After delivering
the rod member, a cap or set screw (not shown) can be delivered
downwardly through the housing 50. The set screw comprises external
threads that mate with the internal threads 61 of the housing 50.
The set screw can apply a downward tightening or compression force
on the rod member. The compression force is translated to the
bushing 30, and the bushing 30 is deformed within the housing 50
(sometimes referred to herein as being "crushed" or "crush-locked")
into more complete contact with the bone screw 10', thereby locking
the bone screw 10' at a fixed angle with respect to the housing
50.
[0051] It will be apparent to those skilled in the art that various
modifications and variations can be made in the present invention
without departing from the scope or spirit of the invention. Thus,
it is intended that the present invention cover the modifications
and variations of this invention provided that they come within the
scope of the appended claims or their equivalents.
* * * * *